Support Epidemiologist (Medical Device Active Surveillance Program)

Support Epidemiologist (Medical Device Active Surveillance Program)

Organization Supported: FDA Center for Devices and Radiological Health (CDRH), Office of Clinical Evidence and Analysis (OCEA), Division 2

Position Overview

The Support Epidemiologist supports the medical device active surveillance program within the Office of Clinical Evidence and Analysis (OCEA), Division 2, at the Center for Devices and Radiological Health (CDRH). The incumbent plays a critical role in translating complex epidemiological and statistical analyses into clear, well-organized, and actionable materials that inform the full lifecycle of active surveillance activities — from initial device selection through ongoing safety reporting and final regulatory decision-making. By maintaining rigorous documentation standards and producing high-quality presentation materials, the Support Epidemiologist ensures that surveillance findings are communicated effectively, that the evidentiary record is complete and audit-ready, and that regulatory stakeholders have the information they need to make timely, well-supported decisions that protect public health.

Duties and Responsibilities

The incumbent serves as a support epidemiologist embedded within a multidisciplinary active surveillance team. The primary responsibilities of this role center on the development, maintenance, and organization of presentation materials and records that inform device selection, ongoing safety reporting, and support regulatory decision-making. The position requires close coordination with epidemiologists, biostatisticians, data scientists, and regulatory reviewers.

The contractor shall:

1. Device Selection Presentations

• Develops structured, evidence-based presentation materials to support the prioritization and selection of medical devices for active surveillance monitoring, incorporating data from sources such as MAUDE and RWD sources.
• Synthesizes device-specific background information, signal rationale, and epidemiological justification into slide decks and briefing documents tailored for internal review panels and leadership discussions.
• Ensures that device selection materials clearly communicate benefit-risk considerations, surveillance feasibility, and data source availability to facilitate informed prioritization decisions.
• Maintains version-controlled records of device selection documentation, including meeting notes, rationale summaries, and supporting analytical outputs.

1. Surveillance Reporting Presentations

• Produces recurring and ad hoc surveillance reports and visual summaries that communicate active surveillance findings to internal audiences, including division leadership, cross-functional teams, and program offices.
• Translates statistical outputs, epidemiological metrics (e.g., observed-to-expected ratios, incidence rates, time-to-event analyses), and data quality assessments into accessible and visually clear presentation formats.
• Maintains a library of standardized reporting templates that promote consistency, reproducibility, and compliance with CDRH documentation standards across surveillance cycles.
• Assists in drafting narrative summaries and interpretive commentary to accompany quantitative surveillance results, ensuring scientific accuracy and appropriate characterization of uncertainty and limitations.

1. Decision-Making Support Presentations

• Prepares briefing materials to support potential regulatory actions arising from active surveillance, including signal evaluation summaries, benefit-risk frameworks, and comparative safety analyses.
• Develops presentation packages for multi-stakeholder meetings and escalation reviews, clearly delineating findings, evidence strength, and recommended next steps.
• Coordinates with senior Active Surveillance Leadership and regulatory leads to ensure that decision-support materials accurately reflect the current evidence base and are aligned with applicable FDA guidance and evidentiary standards.
• Clearly communicates analytical limitations, data quality considerations, and residual uncertainties in all decision-support materials to preserve scientific integrity and support human expert oversight.

1. Organized Record Keeping and Documentation Management

• Maintains a systematic, audit-ready filing structure for all surveillance-related presentations, analytical records, meeting minutes, and correspondence in accordance with FDA records management policies.
• Develops and implements procedures and naming conventions for document organization to facilitate team-wide access, traceability, and retrieval.
• Tracks the status of ongoing surveillance activities, pending deliverables, and action items using project management tools or tracking logs, providing regular status updates to team leadership.
• Supports quality assurance activities by conducting periodic reviews of documentation completeness and consistency across surveillance cycles.

Required Qualifications

• Master's degree in Epidemiology, Public Health, Biostatistics, Health Services Research, Clinical Research, or a related scientific discipline.
• Minimum of 5 years of experience in applied epidemiology, surveillance, or health data analysis, preferably in a regulatory, clinical, or public health setting
• Experience interpreting epidemiologic studies, surveillance findings, statistical analyses, and healthcare data.
• Proficiency in data visualization and presentation software (e.g., Microsoft PowerPoint, Excel); familiarity with epidemiological and statistical concepts relevant to safety surveillance (e.g., signal detection, confounding, time-to-event analysis).
• Demonstrated ability to develop clear, concise, and well-organized technical reports and presentation materials.
• Strong scientific writing, editing, and documentation skills.
• Experience working with multidisciplinary teams and complex scientific information.
• Proficiency in Microsoft Office Suite, especially Word, Excel, PowerPoint, and Teams.

Preferred Qualifications

• Experience supporting FDA, CDRH, CMS, CDC, NIH, VA, DoD, or other Federal health agencies.
• Familiarity with medical device regulation, postmarket surveillance, and active surveillance methodologies.
• Experience working with real-world data (RWD), registries, claims databases, electronic health records, or medical device surveillance systems.
• Understanding of epidemiologic study designs, signal detection methodologies, and safety monitoring practices.
• Experience supporting executive communications, regulatory documentation, or scientific publications.
• Knowledge of healthcare quality systems, documentation requirements, and audit readiness practices.
• Familiarity with statistical software such as SAS, R, Python, or STATA.

Must be a US Citizen or a full Green Card holder.